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Contraceptive Technology Update. 2004 Nov; 25(11): p..Are more women at your family planning facility requesting information on intrauterine contraception? Chances are you are seeing an increase in interest: Almost 30% of respondents to the 2004 Contraceptive Technology Update Contraception Survey say they have performed six to 25 intrauterine device (IUD) insertions in the last year, up slightly from 2003’s figures. The popularity of the levonorgestrel intrauterine system (Mirena IUS, Berlex Laboratories, Montville, NJ) led to an increase in the number of IUD insertions, confirms Joe Childress, MD, an obstetrician/ gynecologist in private practice in San Antonio. Women in the United States have two choices when it comes to intrauterine contraception: the Mirena and the Copper T 380A IUD (ParaGard, FEI Women’s Health, North Tonawanda, NY). More IUD insertions are being performed at the Pinal County Health Department, a public health facility in Florence, AZ, reports Carolyn Brown, RNP, nurse practitioner. The facility uses ParaGard IUDs. (excerpt)
Silver Spring, Maryland, 1979.. 5.As a result of both FDA's review of IUD labelling in the United States and a public hearing on IUD use conducted by an Ad Hoc Obstetric-Gynecology Advisory Committee, FDA announced effective November 7, 1977 new patient and physician labelling requirements for IUDs. The information contained in a patient brochure developed by IUD manufacturers includes both pre- and postinsertion facts describing the effectiveness of IUDs, in addition to directions for use, side effects and contraindications. Warnings are also listed particularly cautioning about pregnancy with an IUD in situ. Physicians received similar detailed information including use-effectiveness data along with communication stressing the need for patient counseling and evaluation. The new requirements are intended to aid both physicians and patients in making informed decisions and choices concerning IUD use.
IUDs: an appropriate contraceptive for many women. DIU: un anticonceptivo apropiado para muchas mujeres.
Population Reports. Series B: Intrauterine Devices. 1982 Jul; (4):B101-B135.This discussion of IUDs covers the following: usage shifts to copper IUDs; issues for the 1980s; comparing the Lippes Loop and copper IUDs; life span of copper devices; steroid releasing IUDs; donor agency supplies; types of devices used; insertion and removal (timing of interval insertion, postpartum insertion, postabortion insertion, postcoital insertion, measuring the uterus, removal, and insertion by nurse midwives and paramedicals); bleeding (risk of anemia, limited bleeding); infection (mechanisms of infection, prevention, treatment, actinomyces); pregnancy (uterine pregnancies, ectopic pregnancies, differences among devices, and subsequent fertility); product and packaging issues (manufacture in developing countries, prices, bulk and individual packaging, methods of sterilizing IUDs, and storage). At this time about 60 million women worldwide are using IUDs, including over 40 million in China. In recent years the total number of users has remained relatively stable. The life table event rates per 100 women, by which IUDs are usually evaluated, are approximately as follows after 1 year of use in large, multicenter studies: pregnancy, 0.5-5; expulsion, 5-15; removal for bleeding/pain (5-15); removal for other medical reasons, 3-9; and removel for personal reasons, 1-6. Continuation rates 1 year after insertion tend to range from 50-85%, high rates for a reversible mothed. Some shift in usage occurred in the late 1970s from unmedicated Lippes Loop to copper releasing IUDs and to a lesser extent to IUDs that release progestins into the uterine cavity. Copper devices now have captured much of the market in the US and Western europe and amount to about 2/3 of the supplies provided by donor agencies to many developing countries. During the 1980s attention should probably focus less on the search for an ideal device and more on the need for family planning programs to identify suitable candidates for IUDs, encourage better health service support for IUD insertion and follow-up, and the newer IUDs more widely available to individuals and national programs. In most developing countries the great majority of IUDs are supplied by various national and international donor agencies that purchase large quantities at the lowest possible price and ship them to government and private programs. No data are available on the number of each type of IUD currently in use. Proper insertion of an IUD is important. Insertion can affect all major events that determine success. While there are several different techniques for inserting IUDs, with each the skill of the operator is critical. Recent studies fo about 10,000 women show that there is no one preferable time for insertion.
[Unpublished] 1980. Presented at the International Family Planning Association Seminar for Pharmacists, Dublin, Ireland, January 30, 1980. 8 p.In this discussion of standards and quality control in contraception, attention is directed to the following: scope; effectiveness; spermicides; diaphragms; condoms; labeling; evaluation; and stage of testing. The oral contraceptive (OC) is 100% effective, and the condom is not 100% effective. Couples limiting their families tend to use OCs most carefully, while couples spacing their families tend to use condoms less carefully. To make a fair comparison between OCs and the condom, it is necessary to compare like with like. In a recent UK study of married women, the 1st year pregancy rate was 5% for OC, 11% for the condom, and 14% for the diaphragm. For women married since 1970, contracepting after their 1st or 2nd pregnancies, the pregnancy rate was 4% for OCs and only 5% for the condom. Combining a good quality condom with a compatible spermicide is theoretically as effective as OCs. In regard to spermicides, their laboratory testing may bear practically no relation to their contraceptive effectiveness. It is plausible to suppose that spermicides satisfying the former International Planned Parenthood Federation (IPPF) Agreed Test are more effective contraceptives than other spermicides. When last submitted, all spermicides widely available in the UK satisfied the former IPPF Agreed Test. There are few national standards on diaphragms and none on other caps. The International Organization for Standardization (ISO) is attempting to fashion an international diaphragm standard. There are many national condom standards and an ISO technical committee is on the way to an international condom standard. It is important to distinguish between so-called electronic testing which is applied to all condoms, and sample testing, which is the concern of condom standards. Electronic testing seeks to eliminate condoms with holes or weak spots. The sample testing esentially checks the efficiency of that process, which may vary widely. Immediatly after electronic testing, the British Standard (1979) prescribes a sampling frequency of 1%. From each production quantum of 10,000 condoms, 100 random samples are taken and inspected for visible defects. The same condoms are then tested for holes. The Swedish State Standard (1972) prescribes the same test for holes, performed on condoms sampled from every batch imported into Sweden. Different standards also prescribe somewhat different tests for condom strength. Most condom standards prescribe dimensions. There are various requirements on labeling, and some standards prescribe instructions on storage and use. 99.5% freedom from holes is achieved, yet the main cause of method failure is a burst condom. It is guessed that at least 1 in 1000 good quality condoms burst, yielding a pregnancy rate of about 0.3/100 woman years.
IPPF Medical Bulletin. 1981 Dec; 15(6):1-3.These policy statements and guidelines from the International Planned Parenthood Federation's (IPPF) International Medical Advisory Panel (IMAP) concern IUDs. The following contraindications to IUD use are recognized: 1) pelvic inflaminatory disease, 2) known or suspected pregnancy, 3) history of previous ectopic pregnancy, 4) gynecological bleeding disorders, 5) suspected malignancy of the genital tract, 6) congenital uterine abnormalities or fibroids distorting the cavity, and 7) anemia, blood coagulation, severe cervical stenosis, copper allergy, Wilson's disease, and others. Generalities regarding appropriate IUDs are: 1) non-medicated devices (e.g. Lippes Loop) are studied for women who may not return for regular check-ups, 2) smaller medicated devices usually cause less menstrual blood loss than the non-medicated devices, 3) smaller devices are better for a smaller uterus and larger devices for the larger uterus, and 4) when a smaller device is expelled it is advisable to try a larger one and vice versa. Dalkon Shields should not be used by the IPPF system and all women using them should have the device removed. Correct insertion of IUDs is important and should be done by properly trained personnel. The timing of insertion is best during the menstrual period. Withdrawal of the applicator while leaving the device in place is the recommended insertion technique. Sterilization of IUDs should follow instructions on bulk-packaged IUDs. Complications include perforation, bleeding and pain, infection, and ectopic pregnancy. IUD removal should be done during menstruation. Good clinical management and follow-up care are recommended.
Adopted. 1977 Oct 2; 3.The statements made in these summary minutes of the OTC Panel on Contraceptives and Other Vaginal Products are provisional in nature and may be modified or revised in subsequent meetings of the Panel or in their final report to the Commissioner of the Food and Drug Administration. At the 35th meeting of the Panel discussion focused on the merits of having information on the relative use-efectiveness of the currently available contraceptive methods including vaginal products in patient labeling. The panel concluded that there was insufficient scientifically valid data to provide any useful information to the consumer. In discussion of the term deodorizing the Panel agreed that deodorizing is a result of cleansing but left for future deliberation the final classification of the term "deodorizing."
Washington, D.C., U.S. Agency for International Development, March 2, 1978. 2 p.The ideal vaginal contraceptive is described in terms of the requirements of any other contraceptive method, i.e., that it be effective, acceptable, deliverable, and safe. In terms of effectiveness, the spermicidal action should be powerful, long lasting, and ideally instantaneous in action. Overkill should be overwhelming. Some type of active dispersal (such as foaming) is probably mandatory. Regarding acceptability, the contraceptive should be easy and convenient to insert into the vagina, and messiness, running, odor, itching, irritation, residue and probably sensation of heat should be minimized. The aspect of deliverability is a positive feature of this method, since it easily lends itself to household distribution. It would be useful for the product to be conveniently packaged in multiple dose packaging as well as in unit dose packaging suitable for vending machines. Stability of the product with respect to heat, humidity, and other physical forces is very important, and cost should be comparable to condoms. The potential toxicity of these kinds of methods is favorable, since they compare favorably with the alternatives. Preparations ought not to contain heavy metals nor be detrimental to the normal vaginal flora. These products should potentially offer considerable protection from venereal disease.
Adopted. 1978 Jun; 8:6.Participants of this meeting included representatives from national and international health agencies, consumer groups, pharmaceutical industry, scientific groups and the general public. The consumer groups proposed that adequate informative labeling (to include list of active and inactive ingredients, expiration date, duration of product stability and directions for use) be displayed in both the outer and primary containers of the products. In the discussion of clinical protocols, it was suggested that double blind and placebo control studies should be used only in rare instances. One workshop report stated that well planned surveillance studies carried out during Phases 3 and 4 testing should be able to generate enough theoretical effectiveness data, and that a monitored multicentered study could permit choice of methods and allow comparisons with other contraceptive methods. An appropriate protocol for evaluation of a new product would involve a 1-year study with 3 month-post study-follow-up using an adequate number of sexually active women (18-35 years old, no history of infertility, have normal menses). Other issues addressed in the meeting included concern for statistical validity and variability encountered in multicentered programs; the need to reduce bias against vaginal contraceptives among health professionals; information exchange between pharmaceutical industry and health care systems; and the Panel's need for effectiveness data.
Family Planning Perspectives. May-June 1977; 9(3):138-140.There have been no IUD-related spontaneous abortion deaths since the occurrence of mass media publicity about the Dalkon Shield and the risks associated with leaving an IUD in place following conception. Scientific publications, drug company labeling changes, drug package inserts, and other professional warnings do not seem to have been as effective as mass media publicity in causing a change in a dangerous clinical practice. It seems that publicity directed against a preventable health problem will affect both clinical practice and public health. Such publicity could be useful in getting doctors to prescribe lower estrogen dosage pills and in getting women to obtain abortions as early in the pregnancy as possible.
Adopted. 1975 Dec 11; 5.The statements made in the summary minutes of the 22nd meeting of the OTC Panel on Contraceptives and Other Vaginal Products are provisional in nature and may be modified or revised in subsequent meetings of the Panel or in their final report to the Commissioner of the Food and Drug Administration. The Panel reviewed the preamble of the Draft Report and identified the following additional issues: 1) labeling for douches is to include the warning "not for prevention of pregnancy;" 2) the use of the term "feminine hygiene" was discussed by the Panel and found to be vague, and it was concluded that a clear statement should be made by the Panel regarding the difference between such vague terms and definite therapeutic terms; and 3) a discussion of the use-effectiveness of contraceptives is needed in the Report. Dr. Pearlman presented a summary on phenylmercuric acetate in vaginal contraceptives along with several other papers, and he summarized comments on the safety of talc based on a transcript of a recent Food and Drug Administration symposium on this subject. Dr. Tyrer discussed 2 references on the microbial flora of the cervix and papers on the detection of vaginal malodors, and Dr. Gordon presented draft statements for vaginal douche labeling. The Chairman designated 3 "ad hoc" subcommittees as follows: 1) to develop standards and testing guidelines in support of the various vaginal douche claims; 2) to review the use of pressure in connection with vaginal douche devices, defining pressure limitations, possible hazards, and unsafe and ineffective practices; and 3) to develop appropriate labeling, instructions, inserts, and warnings with respect to vaginal contraceptives, douches and other vaginal drugs.
San Francisco, San Francisco Press, 1974. 292 p.Despite its high effectiveness, lack of side effects, ease of use, and low cost, condom utilization has declined in the U.S. from 30% of contracepting couples in 1955 to 15% in 1970. The present status of the condom, actions needed to facilitate its increased availability and acceptance, and research required to improve understanding of factors affecting its use are reviewed in the proceedings of a conference on the condom sponsored by the Battelle Population Study Center in 1973. It is concluded that condom use in the U.S. is not meeting its potential. Factors affecting its underutilization include negative attitudes among the medical and family planning professions; state laws restricting sales outlets, display, and advertising; inapplicable testing standards; the National Association of Broadcasters' ban on contraceptive advertising; media's reluctance to carry condom ads; manufacturer's hesitancy to widen the range of products and use aggressive marketing techniques; and physical properties of the condom itself. Further, the condom has an image problem, tending to be associated with venereal disease and prostitution and regarded as a hassle to use and an impediment to sexual sensation. Innovative, broad-based marketing and sales through a variety of outlets have been key to effective widespread condom usage in England, Japan, and Sweden. Such campaigns could be directed toward couples who cannot or will not use other methods and teenagers whose unplanned, sporadic sexual activity lends itself to condom use. Other means of increasing U.S. condom utilization include repealing state and local laws restricting condom sales to pharmacies and limiting open display; removing the ban on contraceptive advertising and changing the attitude of the media; using educational programs to correct erroneous images; and developing support for condom distribution in family planning programs. Also possible is modifying the extreme stringency of condom standards. Thinner condoms could increase usage without significantly affecting failure rates. More research is needed on condom use-effectiveness in potential user populations and in preventing venereal disease transmission; the effects of condom shape, thickness, and lubrication on consumer acceptance; reactions to condom advertising; and the point at which an acceptable level of utilization has been achieved.
Chestnut Hill, Massachusetts, Pathfinder Fund. 1975; 2.2 oral contraceptives provided by the Pathfinder Fund, Norinyl 1/50 and Norinyl 1/80, were discussed in a guide to their use, covering pharmacology, selection of dose, packaging, and management. These drugs, composed of 1 mg norethindrone, a moderately progestational agent and either 50 mcg or 80 mcg of mestranol, act through suppression of gonadotrophin release from the hypothalamus, altering the cervical mucus and interfering with transcervical sperm migration and sperm capacitation. For most women Norinyl 1/50 is an effective preparation. Spotting or breakthrough bleeding may occur in the first 2-3 months use. Persistent bleeding is treated by doubling the dose for 2 or 3 days in these patients and in patients treated with the larger dose having bleeding problems. Contraindications are a history of thromboembolism or cancer or clinically significant hypertension, and these contraceptives should be used with caution with hepatic disease or undiagnosed abnormal uterine bleeding. The pills come in packages of 28 pills - 3 rows of 7 white pills and 1 row of brown ferrous sulfate pills. Norinyl 1/80 is packaged with a diagonal blue line to distinguish it from 1/50. Pills are started on day 5 of the menstrual cycle and taken every day thereafter. Procedure for a forgotten pill is explained. Women should be informed of side effects that may occur in early days of use. Circumstances requiring withdrawal of this treatment were enumerated. This preparation provides almost complete contraceptive effectiveness with discontinuation rates for pill related reasons, 2-10%.
Family Planning Perspectives. 1983 May-Jun; 15(3):146-8.On April 1, 1983, the US Food and Drug Administration (FDA) approved a disposable vaginal sponge of soft polyurethane foam saturated with 1 gm of nonoxynol-9 as a nonprescription contraceptive offering 2 improvements over products already available: ability to leave in place up to 24 hours, and no need for additional application of spermicide for repeated acts of intercourse. Clinical tests show the sponge to be comparable in effectiveness to other vaginal methods including the diaphragm. Although no major medical complications have been detected in studies of the sponge thus far, concern over the possibility of its causing toxic shock syndrome led the FDA to require package labeling recommending that the product not be used during menstruation. The sponge was developed by the V.L.I. Corporation of California and will be marketed for about $1 under the brand name "Today." The sponge must be moistened with water before insertion to activate the spermicide, and is believed to prevent conception by releasing the spermicide over 24 hours, blocking the cervix to some extent, and absorbing sperm. The sponge has undergone 5 years of clinical testing in the US and abroad and is the 1st nonprescription contraceptive to go through the safety and efficacy tests required for prescription drugs and devices. Controlled, comparative tests conducted by the International Fertility Research Program began in 1979 in volunteers aged 18-40 who were randomly assigned to the sponge or another vaginal method. Available results are based on 1582 sponge users and 1579 controls. The data reviewed by the FDA advisory committee were based on 720 sponge users and a similar number of diaphragm users in the US segment. The 12-month pregnancy rates from the US trials were 15.8/100 women for the sponge and 11.6/100 women with the diaphragm, not a statistically significant difference. The US data suggest that about 4% of users will develop allergic reactions such as itching, irritation, and rash.
Irvine, California, VLI Corporation, Professional Relations Department, 1983 Jun. 9 p.A new vaginal contraceptive sponge (Today) successfully completed the US Food and Drug Administration NEW DRUG review process for safety and efficacy on April 1, 1983. The Today sponge will be marketed as an over-the-counter drug. The product consists of a resilient, hydrophilic, polyurethane foam sponge impregnated during manufacture with nonoxynol-9 (N-9), a spermicide in use worldwide for over 20 years. N-9 has been classified as safe and effective by the FDA Advisory Review Panel on OTC Vaginal Contraceptives. Contraception with the Today sponge occurs by: 1) spermicidal action of N-9, 2) sperm absorption into the sponge, and 3) blockage of the cervix. The principal advantage of the Today contraceptive sponge, aside from being available without prescription, is that it separates the act of contraception from that of intercourse, thus permitting for the 1st time, sexual spontaneity with a vaginal contraceptive. Multiple coital episodes are possible with a single sponge. Preclinical USP toxicity studies, mutagenicity assays, allergenic response tests, microbiological studies, and human clinical trials conclusively show no evidence of a significant health risk. The product was found in laboratory tests to be hostile to the growth of Staphylococcus aureas, suspected in the etiology of Toxic Shock Syndrome (TSS). Clinical trials with the Today contraceptive sponge, however, were not large enough to assess the risk of developing TSS. Particular attention has been directed to demonstrating safety with respect to carcinogenicity and mutagenicity. Assays for monomers have continually shown the finished product sponge and the polymeric sponge alone to lack any concerns in this area. These assays are conducted on a continuing basis through a formal stability program now in its 3rd year. This stability program includes accelerated testing at both high and low temperatures for up to 3 months, which has confirmed a lack of product degradation. Further, and most significantly, the product has been subjected to a stringent series of carcinogenicity and mutagenicity screens consisting of both the Ames Salmonella Mutagenicity Test and the Mouse Lymphoma Forward Mutation Assay. These tests have been conducted by both Huntingdon Research Center and Litton Bionetics, and have been successfully passed by the Today sponge in every instance. Phase I trials beginning in 1977 (100 women) demonstrated general acceptability and led to improvements in contraceptive capability. Phase 2 clinical trials beginning in 1978 (400 women) produced a cumulative 6-month life-table pregnancy rate of 5.98/100 women; the protocol called for 1 month use of a single sponge with reuse/washing permitted for a maximum of 10 washings. Phase 3 randomized comparative trials (1600 women) began in 1979 and are ongoing internationally and in the US. This protocol calls for a single sponge use for up to 48 hours wear time. Data to date indicate that sponge effectiveness is in the same range as other vaginal contraceptives. Analysis of the outcome of pregnancies during and after use of the sponge indicates no teratologic or embryologic effects. Of the 719 women in the US studies, 1.7% discontinued because of itching, irritation, rash; 1.9% discontinued because of allergic reactions. These results are consistent with the normal allergenic reactions experienced with the use of N-9. Since insufficient numbers of women in the Phase 3 studies chose to use the sponge for a full 48 hour period, statistical analysis of effectiveness data permits only a single day use recommendation. Thus, in the US, users are instructed to rely on the sponge for pregnancy prevention no longer than 24 hours and to leave the sponge in place at least 6 hours after the last episode of coitus. (author's modified)